U.S. patent number 5,765,560 [Application Number 08/670,843] was granted by the patent office on 1998-06-16 for trachostoma valve and tissue connector and housing for use as a part thereof.
This patent grant is currently assigned to Adeva Medical, Gesellschaft fur Entwicklung und Vertrieb von. Invention is credited to Gerhard Rakhorst, Gijsbertus Jacob Verkerke.
United States Patent |
5,765,560 |
Verkerke , et al. |
June 16, 1998 |
**Please see images for:
( Certificate of Correction ) ** |
Trachostoma valve and tissue connector and housing for use as a
part thereof
Abstract
A tracheostoma valve includes a shut-off valve member (1)
capable of shutting off the valve in response to an egressive air
thrust. The valve includes a blow-off valve member (2) of a design
such that the valve can open in response to an overpressure in the
trachea which exceeds a given value. This blow-off valve member
limits the maximum achievable overpressure behind the valve.
Coughing is possible without prior operation of the valve and
leakage due to excessive overpressure in the trachea is prevented.
The valve may contain a tissue connector and a housing to be
connected thereto.
Inventors: |
Verkerke; Gijsbertus Jacob (EP
Haren, NL), Rakhorst; Gerhard (SN Groningen,
NL) |
Assignee: |
Adeva Medical, Gesellschaft fur
Entwicklung und Vertrieb von (DE)
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Family
ID: |
26646907 |
Appl.
No.: |
08/670,843 |
Filed: |
June 28, 1996 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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244738 |
Sep 7, 1994 |
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Foreign Application Priority Data
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Dec 16, 1991 [NL] |
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9102095 |
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Current U.S.
Class: |
128/207.16;
128/207.12; 128/200.26; 128/912; 128/911 |
Current CPC
Class: |
A61M
16/0468 (20130101); A61F 2/203 (20130101); A61F
2210/009 (20130101); Y10S 128/911 (20130101); Y10S
128/912 (20130101) |
Current International
Class: |
A61F
2/20 (20060101); A61M 16/04 (20060101); A61F
2/00 (20060101); A61M 025/00 () |
Field of
Search: |
;128/207.16,207.12,911,912,200.26,201.22,201.28,206.15,203.11,207.14
;623/9 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0078685 |
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Oct 1982 |
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EP |
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2164424 |
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Mar 1986 |
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GB |
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PCT/EP86/00274 |
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May 1986 |
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WO |
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Primary Examiner: Millin; V.
Assistant Examiner: Srivastava; V.
Attorney, Agent or Firm: Gifford, Krass, Groh, Sprinkle,
Patmore, Anderson & Citkowski, P.C.
Parent Case Text
This application is a Continuation of Ser. No. 08/244,738 filed
Sep. 7, 1994 now abandoned.
Claims
We claim:
1. A tracheostoma valve with a shut-off valve member capable of
shutting off the tracheostoma valve in response to an air
displacement, and a blow-off valve member which opens in response
to a particular overpressure achieved, and
a magnet closure for holding the shut-off valve member (1) in the
closed position, with a first part (6) of the magnet closure being
slidable relative to a second part (7) of said magnet closure, in a
direction transverse to the opening direction of the shut-off valve
member (1), for adjusting the over pressure position.
2. A valve according to claim 1 and said blow-off valve member (2)
comprises an opening (4) which is closable by the shut-off valve
member (1).
3. A valve according to claim 1, further comprising a first part
(9) of said magnet closure being slidable relative to a second part
(10) of said magnet closure in a direction transverse to the
opening direction of blow-off valve member (2), for adjusting the
effective overlap of the magnet closure.
4. A valve according to claim 1, further comprising said valve
having a passage with a substantially rectangular
cross-section.
5. A valve according to claim 1, further comprising a housing (13)
and a tissue connector (14), with the housing (13) being detachably
mounted in the tissue connector (14).
6. A valve according to claim 5, characterized in that the tissue
connector (14) comprises a thin-walled flange (18) of biocompatible
material, extending in radial direction around the valve.
7. A valve according to claim 6, characterized in that the flange
(18) is made of coarse-mesh polypropylene gauze.
8. A tissue connector for use as a part of a valve according to
claim 5.
9. A housing for use as a part of a valve according to claim 5.
10. A tracheostoma valve with a shut-off valve member capable of
shutting off the tracheostoma valve in response to an air
displacement, and a blow-off valve member which opens in response
to a particular overpressure achieved on one side thereof; and
a magnet closure for holding the shut-off valve member (1) in the
closed position, with a first part (6) of the magnet closure being
slidable relative to a second part (7) of said magnet closure, in a
direction transverse to the opening direction of the shut-off valve
member (1), for adjusting the overpressure by varying an overlap of
the magnet closure.
11. A valve according to claim 10, characterized by a magnet
closure for holding the blow-off valve member (2) in the closed
position.
12. A valve according to claim 10, further comprising said valve
having a passage with a substantially rectangular
cross-section.
13. A valve according to claim 10, further comprising a housing
(13) and a tissue connector (14), with the housing (13) being
detachably mounted in the tissue connector (14).
14. A valve according to claim 13, characterized in that the tissue
connector (14) comprises a thin-walled flange (18) of biocompatible
material, extending in radial direction around the valve.
15. A valve according to claim 14, characterized in that the flange
(18) is made of coarse-mesh polypropylene gauze.
16. A tissue connector for use as a part of a valve according to
claim 13.
17. A housing for use as a part of a valve according to claim 13.
Description
BACKGROUND OF THE INVENTION AND FIELD OF THE INVENTION
The invention relates to a tracheostoma valve with a shut-off valve
member capable of shutting off the valve in response to an air
displacement.
THE PRIOR ART
In patients with disorders involving the closure or at any rate a
reduction of the connection between the trachea and the pharynx, it
is known to have the trachea terminate at the throat via a stoma
(opening in the skin).
Such a connection of the trachea to the environment is for instance
fitted in patients who have been treated for an extensive malignant
tumor in the larynx by removing the larynx (including vocal chords
and epiglottis) and in whom the trachea has been closed at the
former larynx.
In order to maintain at least some possibility of speaking, new
vocal chords are formed in the pharynx from muscular tissue, mucous
membrane or connective tissue. Further, another valve is fitted in
the wall between the trachea and the esophagus, capable of allowing
air to pass to the esophagus in the case of overpressure in the
trachea. For realizing an overpressure in the trachea, a
tracheostoma valve of the type described in the opening paragraph
hereof is used. The patient can close this valve by expelling
breath relatively quickly. Subsequently, due to overpressure in the
trachea, an airstream is realized through the further valve and
along the substitute vocal chords for setting those vocal chords
into vibration.
A tracheostoma valve as described above is, for instance,
commercially available under the designation of "ESKA-Herrmann
valve" and is marketed by the firm of ESKA of Lubeck, FRG.
A drawback of such valves is that they also shut off the trachea in
the case of fast egressive airstreams due to coughing. In order to
avoid this, the valve member should be removed from the valve
before coughing or the shut-off valve member should be adjusted to
a coughing position.
A further drawback which presents itself in the use of such known
valves is the frequent occurrence of leakage between the valve and
the stoma, causing interfering noise during speech which, moreover,
further impairs the patient's audibility, which is impaired as it
is.
SUMMARY OF THE INVENTION
The object of the invention is to render it possible to cough
without prior operation of the valve and to overcome the leakage
problem described above.
According to the invention, this object is realized by providing a
tracheostoma valve of the type described in the opening paragraph
hereof with a blow-off valve member which opens in response to a
particular overpressure achieved on one side thereof.
The blow-off valve member opens automatically upon coughing, so
that operating the valve prior to coughing is unnecessary. Peaks in
overpressure that occur during coughing are limited to the height
of the overpressure at which the blow-off valve member opens. As a
result, the load on the connection of the valve to the stoma is
limited, so that leakage is avoided or at any rate prevented.
Because the valve according to the invention does not require any
operation by the patient, it can also be applied in situations
where the patient, due to a trauma, is suddenly no longer able to
breathe via the larynx and through the mouth or nose and a
temporary stoma must be made in the trachea, while there is no
opportunity to instruct the patient about the use of the valve.
The invention is also embodied by a tissue connector and by a
housing for use as a part of a valve according to the invention.
The tissue connector can be implanted in the stoma permanently,
providing an improved sealing along the edge of the stoma, so that
leakage is further prevented. The valve further comprises a housing
in which the valve members are mounted. This housing of the valve
can be easily placed into the tissue connector by the patient and
can also be easily removed therefrom.
The invention will be further illustrated hereinafter with
reference to a preferred exemplary embodiment of the invention, in
which:
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front view of a tracheostoma valve according to the
invention;
FIG. 2 is a side view, partly in section, of the valve according to
FIG. 1; and
FIG. 3 is a sectional view of a tissue connector for use in a
tracheostoma valve according to the invention.
DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION
FIGS. 1 and 2 show a tracheostoma valve according to the invention,
capable of being placed, with its end portion 5 on the side of the
trachea of a patient, into a stoma communicating with the trachea.
The valve-comprises a shut-off valve member 1 adapted to shut off
the valve in response to a rapid air displacement, brought about by
exhaling quickly. In FIG. 2, shut-off valve member 1 is shown in
open position by solid lines and in closed position by broken
lines. The valve further comprises a blow-off valve member 2,
designed so as to open in response to a particular overpressure
achieved on the side of end portion 5 of the valve. In FIG. 2,
blow-off valve member 2 is shown in closed position by solid lines
and in open position by broken lines.
Shut-off valve member 1 is pivotally suspended in the area of its
upper edge 11 and is held in the open position by a magnet 6, which
exerts a force on a countermagnet plate 7 mounted on valve member
1. When the patient carrying the valve shown expels breath at a
particular minimum speed, shut-off valve member 1 will be caught by
the airstream and moved in the direction indicated by an arrow 3,
and shut off the opening 4 as long as an overpressure is maintained
in the valve. Upon inhaling, shut-off valve member 1 is opened
again and held in the open position by magnet 6.
Blow-off valve member 2 is likewise pivotally suspended in the area
of its upper edge 12, but is held in its closed position by a
magnet 9, exerting a force on a countermagnet plate 10 mounted on
valve member 2. When the overpressure on the side 5 of valve member
2 exceeds a particular value, this valve member 2 is pushed open,
pivoting in the direction indicated by an arrow 8. Blow-off valve
member 2 preferably opens at an overpressure just exceeding the
overpressure which occurs during speech, so that the air duct is
also cleared in cases of a lighter cough and the maximum
overpressure behind the valve is kept as small as possible.
Further, by limiting the maximum overpressure in the air duct,
leakage is prevented.
In the valve according to the exemplary embodiment shown, opening
4, closable by shut-off valve member 1, is provided in blow-off
valve member 2. This offers the advantage that when blow-off valve
member 2 is opened, shut-off valve member 1 has pivoted with it, so
that already at a relatively small cross-sectional area of the
valve as a whole, a passage area is provided which is sufficiently
large for the passage of air. This applies to the passage of the
blow-off valve member as well as to the passage of the shut-off
valve member. As a result, the valve as a whole can be made of a
particularly compact design. Further, a small cross-sectional area
of the valve is advantageous for limiting the force exerted on the
valve by an overpressure in the trachea.
Utilizing a magnet 9 for holding blow-off valve member 2 in the
closed position has the advantage that it is released for a long
time at an accurate, constant force, and that the means for
retaining blow-off valve member 2 are of a simple construction and
easy to clean. A particular advantage of utilizing a magnet 9 for
holding blow-off valve member 2 in the closed position is that this
magnet, upon closure of the valve member, does not offer any
resistance and, moreover, shuts blow-off valve member 2
independently.
Of course, other means for holding and, at a particular
overpressure, releasing the blow-off valve member can be used as
well, such as an elastic resistance or a spring system with a
strongly decreasing closing force at an increasing opening angle.
As regards the shut-off valve member, too, instead of a magnetic
stop mechanism--here in the open position--other means can be used
for holding open that valve member.
In the device according to the exemplary embodiment shown, a first
part 10 of the magnet closure is slidable relative to a second part
9 of the magnet closure, in a direction transverse to the opening
direction 8 of blow-off valve member 2, for adjusting the effective
overlap of the magnet closure. Thus, a simple and effective
construction is obtained for a stepless adjustment of the
overpressure at which blow-off valve member 2 opens. Countermagnet
plate 10 is slidable relative to magnet 9. To that end,
countermagnet plate 10 is connected to a slide 27 via a bar 26. The
bar is slidable in a slot 28. When blow-off valve member 2 is
closed, slot 28 is located outside the passage of the valve, so
that no leakage through slot 28 can occur.
Magnet 6 for holding shut-off valve member 1 is also slidable in a
similar manner. Magnet 6 is mounted in a magnet holder 16. Magnet
holder 16 is connected to-an adjusting slide 30 via a bar 17
extending through a slot 29, so that slide 30 and magnet holder 16
are slidable, guided by the slot. By sliding adjusting slide 17,
the overlap between magnet 6 and countermagnet plate 7 is adjusted.
The smaller the overlap, the weaker the air thrust that is required
for closing shutoff valve member 1.
Shut-off valve member 1 is preferably made from soft, flexible and
vibration-damping material, so as to limit noise, like ticking,
during closure of shut-off valve member 1.
The valve according to the preferred exemplary embodiment shown has
a substantially rectangular cross-section. This has the advantage
that in a stoma which forms an opening in a given number of
successive cartilage rings 33 (FIG. 3) of the air tube, the valve
has a passage of a maximum cross-sectional area, so that a
relatively small valve is sufficient to provide a sufficiently
large passage area. Moreover, a better connection of the
tracheostoma valve to adjacent non-interrupted cartilage rings 33
of the trachea is obtained. Cartilage rings 33 are formed by
horseshoe-shaped elements of cartilage, which have their open end
facing dorsally and each extend around the trachea. Cartilage rings
33 are disposed behind each other in longitudinal direction of the
trachea.
Known valves are removed for the night's rest, so that the tissue
around the stoma can contract again at night and connects closely
to the valve again during the daytime. In cases where the
re-contraction of this tissue does not compensate the withdrawal
thereof, the attachment of the tissue to the valve along the edge
of the stoma will worsen increasingly in the course of time, which
eventually will lead to leakage along the valve during speech.
This problem is avoided in the valve according to the exemplary
embodiment shown, in that this valve comprises a housing 13 and a
tissue connector 14, with the housing 13 being detachably mounted
in the tissue connector 14. The housing can be removed, for
instance for cleaning or prior to the night's rest, while the
tissue connector can remain in the stoma and can therefore be
constructed as an implant.
FIG. 3 shows tissue connector 14 in implanted condition. This
drawing further shows a connecting edge 23, which can be engaged by
an O-ring, provided around housing 13 (FIG. 2) of the valve. The
O-ring 31 is disposed in a circular groove 32 in housing 13.
To obtain a stable, reliable implantation of tissue connector 14,
this connector is provided with a thin-walled flange 18 of
biocompatible material, extending in radial direction around the
valve. In implanted condition (FIG. 3), flange 18 is anchored in
connective tissue 21 of the throat and preferably extends from an
inner ring 22 which is provided with a synthetic layer 25. The
synthetic layer preferably comprises a coating of biocompatible
material. Thus, a stable anchoring of flange 18 in tissue connector
14 is obtained.
Flange 18 is preferably made of coarse-mesh polypropylene gauze,
capable of being held firmly by connective tissue 21. As shown
schematically in FIG. 3, connected to the flange on one side
thereof is mucous membrane 20 of the trachea, and on the other side
skin 19 of the throat. It is observed that such a tissue connector
can also be used in stoma's elsewhere, such as an intestinal stoma.
In that case, instead of a housing of a valve, a connecting means
of a suitable recipient is connected to the tissue connector.
* * * * *